Looking at the immense opportunities opening up in the year 2018, the India pharma Inc is firing on all cylinders to take the industry to the next level of growth. The industry insiders are upbeat on the growth prospects of pharma and biotech  industries in 2018 as these sectors are all set to reap the rewards of efficiency and transparency through investments in artificial intelligence made in 2016 and 2017.

The current turnover of the industry is US$ 35 billion or Rs. 2.2 lakh crore. In order to capture new opportunities created by a spurt in the rural economic growth driven by government policies and disease burden , the Indian pharma and biotech  industry are pulling out all stops in manufacturing and research. The companies are also looking to export to regulated markets by enhancing the capability in production and global audits clearances.

With the highly  profitable drugs going off-patent in the recent years, the industry  is optimistic of reaping a windfall. Moreover the companies are raring to be more innovative by developing their own drugs through research and development to expand the global footprint.

According to  Taher Abbasi, COO & Co-Founder of Cellworks Research India, 2018 would witness dynamic changes in pharma & healthcare industry. The sector is all set to move ahead to the next level and is expected to see a huge adoption of artificial intelligence and big data in treatment process. Particularly, AI will help healthcare practitioners in data mining to identify risk factors for providing efficacious clinical treatment. On other hand, the use of precision medicine, real-time personalization, non-invasive monitoring, mobility and cloud will empower the healthcare ecosystem.

The cascade of economic initiatives taken by the Union government could create a pulsating ecosystem for the overall growth of the industry. Some of the significant  initiatives are the  national health policy, drug price control mechanism, skilling pharmacists, pushing generics through Jan Aushadi and mandating prescription of generics among healthcare practitioners, the     action plan for setting up medical devices park and bulk drugs park will go a long way in boosting the prospects of the industry. The government’s  'Pharma Vision 2020' is aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.

Beginning from the upgradation of drug regulatory system and training manpower for better compliance to devising pricing policy with the government’s mandate to provide affordable medicines and  medical devices, to setting up mini drug testing labs at seaports and airports, the industry is now gearing up for  better compliance with current good manufacturing practices (cGMP) by global regulatory authorities , more investment on R&D activities, mergers and acquisition and getting benefits from the Union government’s landmark GST (goods and services tax).

At the same time some of the challenges for the Indian pharma industry are  US price pressure on generics, DPCO, higher compliance cost, global economic uncertainties and tighter scrutiny from both Drugs Controller General of India and global regulators.

However the big positives for the Indian pharma are its efforts to bolster their marketing prowess in the US, EU and Japan besides the Asia-Pacific region. This is by  primarily  focusing on the improvement of production yields; especially of critical products, through process modification; by increasing the productivity of high volume products, investment in  innovation to boost technological capabilities.

As per an IBEF report, the  Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size.  Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share  The sector is expected to generate 58,000 additional job opportunities by the year 2025. The exports of Indian pharmaceutical industry to the US will get a boost in FY18, as branded drugs worth US$ 50 billion will become off-patented.

According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), the country’s pharmaceutical exports which stood at US$ 16.4 billion in 2016-17, are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020.

Biotech taking big strides
From biosimilars and vaccines development to orphan drugs, stem cells, and biologicals, Indian companies are latching on to the Union government's ‘Make in India’ initiative.

Companies from Biocon, Serum Institute, Anthem Biosciences, Panacea, Dr Reddy’s Labs, Wockhardt, GlaxoSmithKline, Bharat Serum & Vaccines, Novozymes, Indian Immunologicals, Shanta Biotechnics and Reliance Lifesciences, to name a few, are the ones who have jumped into the 'Make In India ' bandwagon.

Biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing make-up the canvas of Indian biotech industry.

The Centre for Cellular and Molecular Platforms (C-CAMP), an initiative of the DBT along with the institute for Stem Cell Biology and Regenerative Medicine and National Centre for Biological Sciences, forms the bio-cluster in Bengaluru.
 There is ample activity on the life sciences  start-ups front which are engaged in indigenous research and manufacture of diagnostics, drug development and devising advanced manufacturing technology.

Dominance in generics and biosimilars
After dominating the traditional generic drugs industry for decades, many Indian companies are now in the race to create generic versions of biologic drugs, or biosimilars, which are far more complex to make but offer a large global opportunity, Kiran Mazumdar-Shaw, CMD, Biocon.

In early December 2017, the US FDA’s  approval for Ogivri the biosimilar trastuzumab, co-developed by Biocon and Mylan, marked a major milestone for the former  as it made it  the first company from India to secure a biosimilar approval in the US. Ogivri  has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.

As the first biosimilar from India to be approved by US FDA, the approval of trastuzumab endorses the strength of our country’s science and the manufacturing capability to develop world class biosimilars. It demonstrated that Indian scientists, researchers and engineers are second to none and that Indian biopharma companies can develop advanced therapies that conform to best-in-class global quality standards. Over time, other pharma and biotech companies could emulate our success if like Biocon, they stay committed to the path of innovation and putting India on the world biotech map, said the Biocon chief.

Current regulatory landscape in India
India had in 2016 issued guidelines for ‘similar biologics’ that are based on high science and a strong clinical rationale. The new regulatory regime will enable such drugs to be developed and brought to the market in an affordable and expeditious manner, whilst ensuring quality, safety and efficacy.

Indian pharma companies need to rigorously follow good manufacturing practices, good laboratory practices and good documentation practices throughout their operations with no compromise on compliance to ensure the highest standards of quality at all times. By institutionalizing these quality principles through training and skill development, the industry can ensure it is fully geared to meet the intensified quality scrutiny and address the increasingly demanding benchmarks of regulatory agencies from around the globe, noted Shaw.

Qualified manpower at regulatory departments
The Indian pharma and biotech industry is grappling with a shortage of skilled talent in India. Biocon, as a part of its Corporate Social Responsibility initiative, started Biocon Academy in 2014 to address the skill deficit. Envisaged as a center of excellence for advanced learning in biosciences, the Biocon Academy is focused on creating a well-trained and skilled cadre of life sciences personnel. The 300 students who had graduated from the academy in the last three years are contributing immensely to the Indian life sciences industry through their knowledge, talent and technological orientation. The graduates of the academy were hired for diverse roles in production, quality assurance, regulatory affairs, research & development and marketing, said Shaw.

According to Sumit Kumar, vice president, NETAP, TeamLease Services, the Indian pharma market is expected to grow to US$ 100 billion by 2025 on account of economic prosperity, and increase in urbanization and healthcare insurance.

With government  tax initiative, regulatory reforms and supply of cheap labour ,India continues to be a hot destination for setting up production facilities as compared to the western world. Also, pharma retail which is predominantly unorganized is witnessing a paradigm shift as organized players are entering this segment and setting up pan India chain of pharmacies.

With all this, the sector which employs 2.6 million people currently is projected to go upto four million by 2022. But getting the skilled human resources is a challenge which sector faces across the entire spectrum of jobs like in production, sales, retail and R&D,  he added.